RecruitingPhase 1Phase 2NCT06182969

A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.


Sponsor

Ascentage Pharma Group Inc.

Enrollment

40 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called APG-2575 in people with mild to moderate systemic lupus erythematosus (SLE) — an autoimmune disease where the immune system mistakenly attacks healthy tissues, causing symptoms like joint pain, rashes, and fatigue. APG-2575 works by blocking a protein that helps certain immune cells survive, potentially reducing the immune activity that causes lupus symptoms. **You may be eligible if...** - You have been diagnosed with lupus for at least 6 months - Your lupus is mild to moderate in severity (SLEDAI score between 4 and 12) - You have been on a stable lupus treatment regimen for at least 28 days before the study - You are otherwise in generally good health **You may NOT be eligible if...** - Your lupus is severe or involves major organs like the kidneys or nervous system - You have another significant autoimmune condition - You have had recent serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-2575

Take orally once daily (QD) for 12 weeks.

OTHERPlacebo

Take orally once daily (QD) for 12 weeks.


Locations(1)

Renji Hospital Shanghai Jiaotong University School of Medical

Shanghai, Shanghai Municipality, China

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NCT06182969


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